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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name human metapneumovirus (hmpv) rna assay system
510(k) Number K132200
Device Name PRO HMPV+ ASSAY
Applicant
GEN-PROBE PRODESSE, INC
20925 CROSSROADS CIRCLE
WAUKESHA,  WI  53186
Applicant Contact EMILY ZIEGLER
Correspondent
GEN-PROBE PRODESSE, INC
20925 CROSSROADS CIRCLE
WAUKESHA,  WI  53186
Correspondent Contact EMILY ZIEGLER
Regulation Number866.3980
Classification Product Code
OEM  
Subsequent Product Code
OOI  
Date Received07/16/2013
Decision Date 08/14/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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